Phase 3 Trial Evaluating Lisocabtagene Maraleucel in Second-line Relapsed or Refractory Large B-cell Lymphoma Shows Positive Topline Results
Positive topline results have been published from a phase 3 trial assessing the CD-19 directed CAR T cell therapy lisocabtagene maraleucel as a second-line treatment in adults with relapsed or refractory LBCL.
Positive topline results have been published from the TRANSFORM phase 3 trial assessing the CD-19 directed chimeric antigen receptor (CAR) T cell therapy lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant.
The TRANSFORM trial was a global, randomized, multicenter study, the results of which were assessed through a pre-specified interim analysis conducted by an independent review committee.
The findings showed that the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival. It also met the key secondary endpoints of complete response rate and progression-free survival compared to standard of care.
When the interim analysis was conducted, overall survival data were still immature. However, the safety results were found to be consistent with the known safety profile of lisocabtagene maraleucel for the treatment of LBCL in the third-line setting. Additionally, no new safety concerns were observed in the second-line setting as well.
“We ambitiously designed the TRANSFORM trial to evaluate Breyanzi’s potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard of care regimen of high-dose chemotherapy and autologous stem cell transplant,” said Noah Berkowitz, MD, PhD, senior vice president, Hematology and Cell Therapy Development, Bristol Myers Squibb, in a press release. “These positive interim results build on our commitment to bring CAR T cell therapies into earlier lines and highlight the potential of Breyanzi to transform the treatment paradigm for this difficult-to-treat disease, possibly supplanting the need for patients to undergo current aggressive treatment regimens.”
The results of this trial present the opportunity to look outside the current gold standard treatment of high-dose chemotherapy and stem cell transplant for patients with relapsed or refractory LBCL, because this is the first time a therapy has shown a benefit over this standard of care, according to the study authors. Additionally, the results are the first time a CD19-directed CAR T-cell therapy has shown potential as a second-line therapy in this patient population as well.
Currently, the company plans to evaluate the TRANSFORM data and share the results at an upcoming medical conference, as well as with health authorities.
In February 2021, lisocabtagene maraleucel was approved by the FDA for the treatment of adult patients with relapsed or refractory LBCL after 2 or more lines of systemic therapy, including diffuse LBCL (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B. Additionally, the therapy has not been indicated for the treatment of patients with primary central nervous system lymphoma.
Bristol Myers Squibb Announces Positive Topline Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi (lisocabtagene maraleucel) Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma. Princeton, NJ: Bristol Myers Squibb; June 10, 2021. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-from-Phase-3-TRANSFORM-Trial-Evaluating-Breyanzi-lisocabtagene-maraleucel-Versus-Chemotherapy-Followed-by-Stem-Cell-Transplant-in-Second-line-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.aspx. Accessed June 16, 2021.